Letap Pharmaceuticals Ltd.
⚠️ High Risk
FEI: 3012899910 • Accra • GHANA
FEI Number
3012899910
Location
Accra
Country
GHANAAddress
Plot 107, Graphic Road, B.P. 3346, Accra, , Ghana
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/27/2024 | 56BCA07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/27/2024 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/12/2024 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2022 | 56BCC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) | |
| 3/30/2021 | 56YAH99ANTIBIOTIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/30/2021 | 56YAH99ANTIBIOTIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/20/2020 | 56BCE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2018 | 56BBA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) | |
| 10/27/2017 | 56BCC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) | |
| 9/22/2017 | 56BCE07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) | |
| 9/22/2017 | 62GCE42INDOMETHACIN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 9/7/2017 | 56ECE80TETRACYCLINE (TETRACYCLINES) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 11/4/2016 | 56BDE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/4/2016 | 56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/31/2015 | 56BCF05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) | |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 27DRUG GMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Letap Pharmaceuticals Ltd.'s FDA import refusal history?
Letap Pharmaceuticals Ltd. (FEI: 3012899910) has 19 FDA import refusal record(s) in our database, spanning from 9/21/2005 to 6/27/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Letap Pharmaceuticals Ltd.'s FEI number is 3012899910.
What types of violations has Letap Pharmaceuticals Ltd. received?
Letap Pharmaceuticals Ltd. has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Letap Pharmaceuticals Ltd. come from?
All FDA import refusal data for Letap Pharmaceuticals Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.